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Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration

NCT05587062 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2023-02-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Aflibercept (produced by CinnaGen Co, Iran) compared with Eylea® (Regeneron, USA) in subjects with Neovascular Age-related Macular Degeneration (nAMD).

All the participants will receive one of the following regimens:

Aflibercept (CinnaGen Co, Iran) or Eylea® (Regeneron, USA), 2 mg (vial 0.05 ml) by intravitreal injection every 4 weeks for the first 3 injections, followed by 2 mg every 8 weeks until week 48 of study.

The primary objective of this study is to verify the non-inferiority of Aflibercept (CinnaGen Co, Iran) versus Eylea® (Regeneron, USA) in achieving maintaining vision (losing\<15 letter on ETDRS chart) at week 52 in comparison to week 0 in participants with Neovascular AMD.

Conditions

  • Age-Related Macular Degeneration
  • Neovascular Age-related Macular Degeneration

Interventions

BIOLOGICAL

Aflibercept (CinnaGen Co, Iran)

Aflibercept (CinnaGen Co, Iran) by intravitreal injection

BIOLOGICAL

Aflibercept (Regeneron, USA)

Aflibercept (Regeneron, USA) by intravitreal injection

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05587062 on ClinicalTrials.gov